Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PPMX-T003.
- Who it may be relevant to
- Registry conditions: Aggressive NK Cell Leukemia. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicenter, Open-label, Dose-escalation Phase I/II Study to Evaluate the Tolerability, Safety, Efficacy and Pharmacokinetics of Repeated Continuous Intravenous PPMX-T003 in Patients With Aggressive NK Cell Leukaemia (ANKL) (Physician-initiated Clinical Trial)
Overview
This is Phase I/II Dose-Escalation Study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PPMX-T003 in aggressive NK-cell leukemia.
Interventions
- Drug PPMX-T003
The therapeutic agent is administered continuously intravenously
Primary outcome measures
- Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the first course) [Time frame: 7days after the administration]
Secondary outcome measures (7)
- Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the second course or later) [Time frame: From the second course to the final course (Max. 35days after the first administration)]
- Efficacy of PPMX-T003 repeated continuous intravenous administration (1) Liver volume evaluated by CT scan [Time frame: 35 days]
- Efficacy of PPMX-T003 repeated continuous intravenous administration (2) improvement in liver function as assessed by the Model for End-stage Liver Disease (MELD and MELD-Na) [Time frame: 35 days]
- Efficacy of PPMX-T003 repeated continuous intravenous administration (3) Survival duration at 6 months [Time frame: 6 months]
- Efficacy of PPMX-T003 repeated continuous intravenous administration (4) Percentage of subjects who were able to transition to chemotherapy [Time frame: 35days after the treatment]
- Serum drug concentration during repeated continuous intravenous PPMX-T003 administration [Time frame: 35 days]
- Anti-drug antibody production (Immunogenicity) [Time frame: 35 days]
Eligibility criteria
Inclusion criteria
- Patients diagnosed with ANKL (regardless of whether the disease is first or recurrent) based on diagnostic criteria developed with reference to the World Health Organization (WHO) 4th edition (2017) criteria.
Exclusion criteria
- Patients eligible to receive chemotherapy as treatment for ANKL
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 1 center
- Hiroshima University Hospital — Hiroshima
Publications
- Fukuhara N, Onizuka M, Kanda J, Asada N, Kato K, Ando K. Protocol for a multicentre, open-label, dose-escalation phase I/II study evaluating the tolerability, safety, efficacy and pharmacokinetics of repeated continuous intravenous PPMX-T003 in patients with aggressive natural killer cell leukaemia. BMJ Open. 2025 Jun 30;15(6):e098532. doi: 10.1136/bmjopen-2024-098532. PMID 40588385
Identifiers
NCT: NCT05863234 · PPMX-T003-CT103